November 24, 2025
Now, data is more valuable than ever — and that makes protecting it more important than ever too. When it comes to personal and health-related information, two major regulations stand at the forefront: GDPR (General Data Protection Regulation) and HIPAA (Health Insurance Portability and Accountability Act).
Both laws are designed to protect people’s privacy and ensure that organizations handle sensitive information responsibly. But they do this in different ways, with different rules, and for different regions of the world.
This article will help you clearly understand how GDPR and HIPAA compare, how they differ, and what organizations need to do to stay compliant with both.
The General Data Protection Regulation (GDPR) is a data privacy law introduced by the European Union (EU) in 2018. Its main goal is to protect the personal data of people living in the EU — regardless of where the organization handling the data is based.
That means even a company in the U.S., Asia, or the Middle East must follow GDPR rules if it processes the data of EU citizens.
Key goals of GDPR include:
Scope: GDPR applies to all companies and organizations that collect, process, or store personal data of EU residents.
The Health Insurance Portability and Accountability Act (HIPAA) was enacted in the United States in 1996. It focuses specifically on health information and sets standards for how healthcare providers, insurers, and business associates manage and protect patient data.
HIPAA’s main goal is to ensure that a person’s Protected Health Information (PHI) — such as medical records, health history, or insurance details — remains private and secure.
HIPAA covers three main rules:
Scope: HIPAA applies only within the United States and to entities involved in healthcare services — including hospitals, clinics, insurers, and their subcontractors.
Before we dive into differences, it’s helpful to see what these two regulations share in common. Both laws:
While both GDPR and HIPAA deal with data protection, they do so in very different ways.
Here’s a clear comparison table to show how they differ:
Aspect
GDPR (EU Regulation)
HIPAA (US Law)
Geographical Scope
Applies to any organization processing EU residents’ data, worldwide
Applies only within the United States
Data Type Covered
All personal data (name, email, location, IP address, etc.)
Only Protected Health Information (PHI)
Who Must Comply
Any business handling EU data
Healthcare providers, insurers, and business associates
Individual Rights
Access, rectification, deletion (“right to be forgotten”), portability
Limited rights — individuals can access and request corrections to their PHI
Penalties for Non-Compliance
Up to €20 million or 4% of annual global turnover
Up to $1.5 million per year per violation type
Legal Basis for Processing
Consent, legitimate interest, legal obligation, etc.
Authorization required for use/disclosure of PHI
Regulatory Body
EU Data Protection Authorities
U.S. Department of Health and Human Services (HHS)
Focus Area
General personal data protection
Healthcare-specific data protection
Even though GDPR is an EU law, healthcare organizations around the world may still fall under its scope.
For example: If a U.S.-based hospital treats a patient who lives in France or Germany and stores their information digitally, GDPR rules may apply.
Healthcare providers that operate internationally must therefore ensure dual compliance — adhering to both HIPAA and GDPR.
This includes:
While HIPAA protects Protected Health Information (PHI), GDPR protects Personal Data — a much broader category.
Here’s how they differ:
Category
Definition
Examples
PHI (HIPAA)
Any information that identifies an individual and relates to their health condition, care, or payment
Medical records, lab results, insurance claims, prescriptions
Personal Data (GDPR)
Any information that can identify an individual directly or indirectly
Name, ID, phone number, email, photo, IP address, location
In simple terms: All PHI is personal data, but not all personal data is PHI.
One of the most notable differences between GDPR and HIPAA lies in data subject rights.
Under GDPR, individuals have the right to:
Under HIPAA, individuals mainly have the right to:
GDPR therefore gives individuals far more control over how their data is collected, used, and shared.
Both GDPR and HIPAA require organizations to report data breaches — but their timelines differ significantly.
Regulation
Notification Deadline
Who Must Be Notified
GDPR
Within 72 hours of discovering a breach
Supervisory authority and affected individuals (if risk is high)
HIPAA
Within 60 days of discovery
Department of Health and Human Services (HHS) and affected individuals
GDPR’s 72-hour rule is much stricter, pushing organizations to act faster in protecting data subjects.
Both GDPR and HIPAA impose serious penalties on organizations that fail to protect personal or health data. However, the scale and impact of these penalties differ.
Under GDPR, organizations can face fines up to €20 million or 4% of their annual global revenue, whichever is higher. This makes GDPR one of the strictest privacy laws in the world.
HIPAA, on the other hand, follows a tiered penalty system, where fines range from $100 to $50,000 per violation, with an annual maximum of $1.5 million depending on the level of negligence.
While GDPR aims for global accountability, HIPAA focuses on enforcing compliance within the U.S. healthcare system.
Both regulations strongly emphasize the need for solid technical safeguards to keep sensitive information secure. GDPR requires a risk-based approach, allowing organizations flexibility as long as the data remains well protected.
HIPAA, however, outlines specific requirements, particularly for electronic protected health information (ePHI). These include encryption, user authentication, secure data storage, and access control.
Under GDPR, transferring data outside the EU is restricted unless:
HIPAA does not specifically regulate international transfers, but U.S. healthcare entities that interact with EU patients must follow GDPR’s stricter requirements when moving data abroad.
To stay compliant with both GDPR and HIPAA, organizations should:
Following these practices helps organizations create a strong privacy culture and reduce the risk of costly penalties.
Yes, GDPR and HIPAA can work together effectively, especially for organizations that operate in both the U.S. and EU. While GDPR covers a broader range of personal data, HIPAA focuses only on healthcare information.
By combining both frameworks, companies can create a comprehensive data protection strategy that respects privacy and security across all regions.
In practice, implementing strong consent policies, maintaining transparent data use, and applying high-level security standards will help meet the requirements of both laws simultaneously.
The overlap between GDPR and HIPAA reflects a growing global shift toward stronger privacy standards.
Other regions — including Canada (PIPEDA), Brazil (LGPD), and the UAE (PDPL) — are adopting similar laws. This signals a move toward universal principles of privacy, emphasizing trust, security, and accountability.
As healthcare becomes more digital and global, organizations must adapt to a privacy-first mindset, not just compliance checklists.
Both GDPR and HIPAA share the same ultimate goal — to protect people’s privacy and secure their sensitive information. However, they differ in scope and enforcement.
GDPR is a global regulation that applies to all types of personal data, while HIPAA is a U.S. law designed specifically for healthcare data.
Organizations that deal with international patients or digital health services must understand and comply with both.
By doing so, they not only meet legal obligations but also build greater trust and transparency with their users.
Yes. If a U.S.-based healthcare provider or any company handles the personal or health data of EU residents, it must comply with both HIPAA and GDPR. This usually applies to international healthcare systems, telemedicine platforms, and research institutions working across borders.
Both laws have strict enforcement policies. Under GDPR, fines can reach up to €20 million or 4% of annual global turnover, while HIPAA penalties can go up to $1.5 million per year per violation type. In addition to financial penalties, violations can also lead to lawsuits and reputational damage.
Yes, but the way it works differs. GDPR requires clear and explicit consent for processing any personal data, while HIPAA focuses on obtaining written authorization before using or disclosing a patient’s health information for purposes beyond treatment, payment, or healthcare operations.
Under HIPAA, medical records must generally be retained for six years from the date of creation or last use. GDPR, however, does not set a fixed retention period. Instead, it requires that personal data be kept only as long as necessary for the purposes it was collected.
Organizations can ensure compliance by adopting a privacy-by-design approach, encrypting all sensitive data, regularly conducting risk assessments, training employees on privacy policies, and maintaining clear data processing records. It’s also advisable to appoint a Data Protection Officer (DPO) or compliance officer to oversee ongoing adherence.
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